Time commitment, money and other practical issues

Some trials involved only a one-off or fairly short commitment from patients, and had little impact on their lives. In Caroline’s case, for example, the trial was testing the effect of a computerised decision-aid and required only minor practical commitment.

Caroline used to work as a physiotherapist. She's married with 2 children aged 5 and 2, to whom she's now a full-time mother. Ethnic background/nationality' White British.

I was given a CD-ROM to look at and I think I was shown how to do it, how to use the computer - in fact I think the person, the researcher, came and sat with me while we looked through it. And she was very good. She allowed enough time, you know, she said, “Have you finished? Have you finished reading that page?” We moved to the next one and, and so on. So I felt that it was done quite well, really, quite considerately. But I think pregnant women - well, certainly for myself, I mean to a certain extent your brains do turn to mush a little bit [laughs]. So I probably just went through it with her and I would have found it quite difficult to concentrate probably.

I can remember it did go on quite a long time, and a lot of it seemed to be similar stuff over and over again, put in a different way just to sort of make it crystal clear. So I think that probably, whether I took in all of the information on the screen at the time or not, I wouldn’t like to say. Probably not.

And did they then follow you up and check what actually happened, whether your decision was what actually happened in reality?

Yes, they - well, no, they didn’t check up on what kind of labour I’d had until the final part of the study, which was to check. I had another questionnaire to fill out about whether the information I’d been given had influenced my decisions. So it didn’t seem they were particularly interested in my experience. They were interested in what the questions were that they’d been asking particularly. So I don’t remember them particularly getting involved in whether it had made me feel better or worse, or any of that. It was more to do with, “Right, well, has our question been answered or not?” And then they did give me a final bit of input, where I’d asked to be notified about what the results were, because I was interested. And they did get back in touch.

And can you remember what the results were that they --

Yes, the results were positive and showed that the more information women have and the better it’s delivered, that the more confident they feel about the decisions they’re making.

However, other trials made greater demands, and for a longer period: people had to think about a range of practical implications, such as travelling, time off work, holidays and money. No-one we talked to had been put off by the amount of time required for them to take part in a trial. But some had heard of other people who had said no for this reason, and it had made some people withdraw or think about withdrawing. (See ‘Thinking about withdrawing from a trial’).

Anthea is a retired administrative officer. She is married. She had one grown-up daughter, who died. Ethnic background/nationality' White British.

The drug company did compensate when because the first two sessions I had to come weekly, and I had to be in the whole of one day. And then the second treatment was, was slightly different to the first treatment and I had to be in overnight, or go home and come back early the next morning, which is what I did. But the drug company actually paid our petrol money just for the first sort of two trials. But even if they hadn’t, I’d have still have done it. It, you know, it wouldn’t have made that much difference. It’s petrol money. It’s nothing if, if something’s going to work.

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Age at interview:

61

Sex:

Female

Background:

Danny is a retired teacher, who now does voluntary work with her grandchildren and their schools. She is married with 2 adult children. Ethnic background/nationality' White, mixed ethnicity.

Anyway, then I told him - this trial started in July, I’m sure it was July - and I told him that I was going to France, because as an ex-teacher I still live by school holidays, especially as I’ve got grandchildren and we all go on holiday together. And I said we were going away for a month. Well, that threw them into some degree of apoplexy, and they said, “We might have to exclude you from the trial.” Well, where I come from, in my language exclusion’s bad, you know [laughs]. You get excluded from school for doing bad things. Have I done something bad? Not, “Oh dear, [tut] should have really thought about the summer holidays because there’s going to be a lot of people who might not be able to get up here because they’ve got children to look after, etc etc.” So there is an element of not taking on the wider life. Now, nobody - I mean although I told them I was retired, throughout the trial there was an assumption, a tacit assumption, that I was available. Had they said to me at the outset I could have given them my availabilities, and mine are very flexible. Now, it raised the question with me, are they not random trials? Are they just trials for people [laughs] that can go up there at the drop of a hat, or are retired and sick, or unemployed?

Because that issue was not addressed in the screening that got me there, and so because it wasn’t addressed it became a bit of an issue because I wasn’t available.

But it wasn’t a big deal, so the doctor went and spoke to the senior doctor.

Sarah commented on the arrangements she had to make to take injections with her on holiday during the trial “I even had to go on holiday, abroad - in fact it was my honeymoon - and I had to take the injections with me and have a letter to show at customs, in case they thought I was a drug addict.

The implications of physical side effects are discussed in more detail in ‘Side effects and queries’, but also had a bearing on practical issues such as taking time off work. In Wendy’s case below, the trial involved an extra six months of chemotherapy and side effects, and she had to stop working.

Wendy is a teaching assistant. She's married with 3 children aged 16, 14 and 14 Ethnic background/nationality' White British.

I’ve got three children, and at that time they were, what would they have been? 12 and 14 - two 12-year-olds, a 14 year old. And it was an increasingly, you know, my son was going through GCSEs starting. And I didn’t really think, because I’m so active and I’m so involved with their education and their, their home life. As a family we’re really close knit, we do everything together, we’re self-sufficient, we don’t ask anybody else to help out. It’s the way we’ve always had to live. And the thought of them not having Mum around for what could be - because I was warned that if the side effects were really at their worst, you know, for the next twelve months the fact of the matter would be I would be not able to do anything. I said, sat them all down. We, it was a family decision, it wasn’t just my decision. You know, “We might not be able to go on holidays. I might not feel up to it. It means, you know, I won’t be able to drive you here, there and everywhere.” Because the children have lots of after-school activities. They’re both heavily involved with the church, with boys’ and girls’ brigade. “There’d be none of Mum ferrying you here, there and everywhere.” Also on top of that I knew that they were telling me I wouldn’t be well enough to work, and I understood that after a few months I would lose my salary. So that would have an impact on the family as well. And I just felt that, my husband works very, very long hours, so when the children came home from school, what inevitably happened, and I did actually discuss this with my son in the first couple of months because I felt so bad at that time, that [clock strikes three] it wasn’t fair for me to expect a 12 or a 14-year-old to look after their mother when it was an important time for them in school.

That did happen. And I felt really immensely guilty that, “I’m their mother. I’m the one that should be looking after them, and they’re looking after me” or that’s what I was assuming would happen. And, as I say, they all sat down and my son especially, the oldest one, because he’s very mature for his age, said, “Mum, it doesn’t really matter. We don’t mind if we don’t have a holiday, we don’t care if we don’t have a holiday as long as you get better. And if it, if it helps you to get better, if it’s a, you know, strong drug and it’s got all these side effects, we’ll get through it. Don’t you worry about us. We will do it.” And so that, that’s the way I had to sort of think about it.

And tell me a bit about how the side effects did actually affect you and having to go into hospital every three weeks, I think you said.

Yes, yeah.

What kind of effect did it have on your life in the end?

Well, at the start it meant my husband had to have a day off each time I went, because I wasn’t well enough to drive. So every three weeks my husband would have to take a day off, having had all the time off when I was in surgery at the beginning anyway. So that impacted on us. Financially it impacted on us, because it was a long drive there and back, every three weeks. And then if there were any hiccups and my blood pressure rose or my temperature shot up, I would have to go and have blood tests, and I might be asked to stay in overnight at the hospital till everything settled down. So there was a potential for that as well. So the cost implications on the travelling, the time impact on my husband with his work, that also meant that that third, once every three weeks my children came home to an empty house, no parents around. And it could have been for a lot, you know, a long time. It depended on what time of day my treatment was at. So it impacted more financially than, than anything else. But we got into a routine. We, you know, we did sort of quickly get into a routine of, “This is what’s going to happen” and we knew what to expect. But the side effects peaked and troughed a bit really, as I suppose they do in any, any sort of three-week cycle of chemotherapy.

Elizabeth felt doctors did not always appreciate the level of commitment people were making.

Elizabeth is a nurse. She is married with 2 grown-up children. Ethnic background/nationality' White British.

I think it’s very difficult, because you have got to have trials, you have got to have something to prove that something works before it becomes licensed, and I think that that’s important. But I don’t think there’s always quite the understanding of the implications of taking part in a trial, and going through what people go through, and experiencing what may seem to a clinician’s point of view a minimal side effect, may not be minimal at all, you know. It may be something that makes a huge difference between somebody going back to work and somebody not going back to work, and all the financial implications that that involves.

What do you think could be done better to improve clinicians’ awareness of that, the patient perspective?

…I don’t know, apart from them going through the experience themselves [laughs]. Somebody was saying to me, I was discussing with somebody about something the other day, and I almost felt irritated because I could see that he had no idea what it was like to be in that situation at all, and he was saying, “Of course you’d do this, and of course you’d do that”, and I thought, “You don’t know, because if you’d been in that situation, if you’d just been through major surgery, you’ve just had six months chemotherapy, you wouldn’t necessarily come to that conclusion.” …it’s difficult because people want to be told about these things, and they want that opportunity to help. I think it’s very difficult to change it because you’ve got to press it a bit, really, for people to take on board and if people don’t take part in these trials, then you’re never going to get any results.

Many people, of course, continued to work, and not all trials involved major side effects. However, attending regular appointments often still amounted to quite a commitment. Some mentioned supportive employers who allowed staff to take time off work for trial appointments. Others said they had to take their own annual leave to cover time off, or felt they could only take part because they were retired. Several commented that trials needed to be more flexible rather than expecting people to attend during the working day, especially when people are not seriously ill, or when taking part is mainly to help research rather than offering any direct personal benefit.

Sabiha is a medical secretary and a counsellor. She has 2 children aged 26 and 17. Ethnic background/nationality' Pakistani.

And what did they tell you at that point? What was their explanation of what would be involved if you’d gone through with it?

Yes, they said that I’d have to go there, to the, to a particular hospital for a couple of hours at a time. And then it entailed a few blood tests and other tests, and some, a couple of, I think one full day and a half day, and things like that. So they did explain to me what it would involve, what, how much of my time and everything.

And would that have worried you, having to spend time going to appointments and so on?

Not really, because I was going to be taking my own leave to do all that. So because I have lots of leave, I was prepared to take my own leave and let them do the research.

So it would have had to be your unpaid time? Or your holiday time?

My holiday time, yes.

Which is okay if you’ve got plenty left.

Yes.

Yeah.

But if you haven’t, then obviously it’s something that, you know, not many people would do if they weren’t, you know, they were pushed financially, not to have the money that they usually have, because it’s not easy.

Did you actually ask your employers if you would have been able to do it on paid work time?

No, I didn’t, because I have a feeling that they would have not allowed me to, because they’d say that, “Your work will suffer. And who’s going to cover you?” and things like that. So that’s the thing. Because one’s not covered if - especially now I think it’s getting harder - that if you’re on leave or if you’re on sick leave, there’s no cover and you come back to a pile of things. So that’s, that’s the… that’s the bad side of it, I would say, yes.

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Age at interview:

64

Sex:

Female

Background:

Rosamund is a university professor, with 3 adult children. Ethnic background/nationality' White British.

I’ve said a bit about how I think the recruitment process could have been improved. You know, it was unnecessarily wearing, and I could have easily have dropped out at that point because, you know, there was a difficulty. It wasn’t actually possible to have a conversation with someone and fix a time that I could easily do. That wasn’t possible. It was a matter of returning letters, being sent another appointment which was, of course, always during the day. I mean this went on, it went on for several months and I can’t believe that there weren’t other people in my situation that, you know, there also probably were people who had to take time off work, even unpaid time off work, in order to be recruited into this trial. I don’t think people should be paid to take part in research, I’m not saying that at all, but I think there should be an awareness of the fact that you have to put yourself out to go through this process even if you’re in the control group. You know?

Most people were not happy with the idea of being paid to take part, and worried it might attract people for the wrong reasons.

Angela is a retired former head teacher and special needs adviser. She is married with two adult sons. Ethnic background/nationality' White British.

I think one of the things that I actually find quite irritating is that people - I understand that money is, is an incentive. I want good health. I don’t need rewarding. I find it quite off-putting. But I do understand that in order to get volume in trials you’ve got to have some kind of incentive for people to go into them. And if they’re not aware or they haven’t got health problems of their own, then I can understand how it’s come about. I’m not comfortable with it at all.

So you’re thinking about the ones where it’s the first time they’ve tried it out in people and they pay people to come along and take part.

Well, it isn’t only just first time. I mean, quite a lot of them are well advanced in the research so, no, I just, I’m not comfortable with the idea of being rewarded to do something which I do because I think I should be doing it. It’s morally right.

If people don’t volunteer, they’re never going to make any progress. You’re going, we need to find out which is the appropriate drug and if the majority of doctors are prescribing something else - it’s quite helpful as well to know about what there is available, which you don’t know immediately you go in, but then, of course, you become informed, so yeah, yeah. It’s important that people do volunteer, if they can. I mean, I was in a fortunate position in that I’d already taken early retirement from education, so I, it wasn’t a commitment that was going to take money out of my pocket or interfere with a job. I still would have done it regardless, but it’s easier that way, mm.

Paying people to take part normally only happens in early-stage trials involving healthy volunteers, and even then it is more officially referred to as ‘compensation’. The level of compensation is dependent on trial length, inconvenience/disruption to normal life and possible discomfort involved, for example from having lots of tests. However, as Angela noted, people in other kinds of trials may also be offered some financial compensation. In this study, we interviewed only people who were taking part in trials because of a condition they already had, or as part of prevention or screening for health problems. While most were paid nothing or minimal travel expenses, some were paid other amounts, or had drugs provided free that they would otherwise have paid for. (See also ‘Reasons for taking part – personal benefit’). This was generally not a main reason for taking part, however.

Wendy is a teaching assistant. She's married with 3 children aged 16, 14 and 14 Ethnic background/nationality' White British.

They said that I wouldn’t get paid for going in the trial, there was no financial gain, and now I come to mention it they were going to let me know of the outcome of it, I will get told about the outcome of the trial, but it won’t be for over five years. There was no financial gain, I’d get access to the final results in five years’ time, and any medicines that I needed relative to the treatment they would provide me with. However, when I got certain side effects, I had to go to my GP about the mouth ulcers and whatever, I was prescribed things by the doctor, rang the hospital and said, “How do I go about getting these without having to pay for them?” They said, “Ooh, no, you have to pay for them.” And I thought, “Well.” So they must have meant the traditional sickness and diarrhoea, but I was also told you would get these, you could get mouth ulcers, which I got. And I had to go through my GP and get [door bell chimes] prescribed drugs and pay for those. So that was a bit of a, that was a naughty one. Because that, when you’re earning no money at all, and it’s over six pounds something a go, was a lot of money.

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Age at interview:

56

Sex:

Male

Background:

David is a full-time student. He is single.

The clinical trial I was involved in came through my GP and the practice that I was a patient of at that time had a very good asthma clinic. So through that, I was asked if I would be interested in participating in a trial at the [specialist] Hospital which would be educative for me, and would be helping to find an up-to-date cure for asthma. So I looked into it, and I went to meet the doctor in charge of the trial, and it was very much sold as an altruistic thing, that we would be helping people with the same condition. And I decided to do it because I was interested in what the trial was about. I have to say that there was a fairly generous sort of expenses package [laughs]. That was one of the factors, I have to say.

I mean, it was about a thousand pounds, actually. But I mean it was quite a lot of work, actually, to actually remember to take your peak flows three times a day, and to fill in the paperwork was, you know, quite a lot of work really, so I think the remuneration was probably quite appropriate. If you add up all the travelling and the time taken to actually do the peak flow and fill in the paperwork it probably wasn’t that much, actually.

There is considerable debate about how far it is appropriate to compensate people financially for taking part in clinical trials, and the term ‘expenses’ has many possible meanings. Covering people’s travel costs is common, and is usually seen as reasonable and ethical. Compensating people for their time is less straightforward. Some see it as acceptable, especially if a person has had to take unpaid leave, while others feel it constitutes a payment and may put pressure on people to take part.

A few people felt it may be justifiable to pay people in certain circumstances.

Sabiha is a medical secretary and a counsellor. She has 2 children aged 26 and 17. Ethnic background/nationality' Pakistani.

And I don’t know if sometimes people can’t take part in it because of time. And if they’re committed and they’re working and they’ve got a full-time job, to take time off is not easy. And I think it would be nice if all these trials are a bit flexible, in that they try, I mean they do these kind of tests at weekends and evenings. Then there might be more people that would come forward, because during the day when people are working they’re committed and it’s difficult for them to take time off.

What do you think about paying people to take part in trials? Obviously with the kind of the Northwick Park* ones, that’s different.

Yes.

But in these kind of routine healthcare kind of trials, what do you feel?

I think more people would take part if they were paid for these trials. Sometimes it might not be possible for the trial organisation to pay them, because of funding or whatever. But I think more people would take part if they were paid for what they were taking part in, because it is, it is, I mean, their commitment. And if they’re taking part, I think if they’re not paid, it’s nice of the people to give their time. Whereas if they were paid, there would be more people that would take part in it, because at least they would get some kind of token for what they’re doing. So it’s, it’s important, really. But as I said, sometimes the funding gets in the way. And it’s, it’s not the person who’s doing the research, it’s not their fault. It’s somewhere else where the problem lies, but they might have to face the music.

I think also there are sometimes ethical issues about paying people, and whether then people are going to feel kind of pressured into taking part because there’s money attached to it.

Well, it’s not, it’s not a binding on anyone. It’s their own choice. So I think if they’re getting paid it’s not, it’s not really putting pressure on them. It’s their choice. It’s, you’re not, you’re not being forced to do something against your wishes. So it’s not, it’s not something that they’re forced to do. So it’s their choice.

* FOOTNOTE' The interviewer is referring to a Phase 1 trial at a commercial research unit based at Northwick Park Hospital in 2006 when 6 healthy volunteers became extremely ill. ‘First-time-in-humans’ studies are carried out precisely because we need to find out about possible risks and side effects before giving the treatment more widely. Most of the people we talked to took part in trials of treatments which had already been tested in humans before.

A copy of the Inquiry Report of this incident can be downloaded from the Department of Health website'

Anton is an auditor. He is single. Ethnic background/nationality' Sri Lankan. (You can see more of Anton talking about his experiences of depression on our site on Mental health' ethnic minority experiences, Interview 13).

Have you been in a mixture of some trials that you’ve been paid for and some you haven’t?

Yeah, that’s right. Now my main thing for going for the trials is to alleviate my pain and suffering. I’m not bothered whether I get paid or not. Even when you get paid it’s about 25 quid or 50 quid, and nothing much. So that doesn’t bother me, but the only thing is that if they start paying a decent amount of money that may attract the wrong people. That I’m quite against it.

When it is a commercial organisation, then I will look for a fee, because they’re not a charity. I will tell them up front, “Well, you’re a commercial organisation, aren’t you? So why can’t you pay for my time and trouble?” Some commercial organisations, though, they try their luck.

They want to carry out a survey, and then, “Oh, before we call you for the trial, you’ve got to answer all these sort of questions.” Then after you’ve answered all the questions they said, “Sorry, you don’t qualify for this.” Then I thought, “Ah, they’ve done the market research on a mug like me”. So after about half a dozen enquiries like that, I get wise to it. Then I said, “Oh please take my name off your list, since I joined your company I haven’t earned a penny.” But then there’s some companies they’re quite genuine which I find, so then I’m on their list and when I look up the e-mail, then they will say, “Oh, we are conducting a trial on such and such a thing. Would you like to take part?” and then I go along, yeah.

However, David wanted to get a message across to people that they should think again if money was their only reason for taking part.

I think clearly the ones that people do just for money, they target students, don’t they, and travellers, people who are travelling from Australia. I’ve noticed in a couple of the Australian periodicals that there’s tons and tons of ads in the back of those for clinical trials. And that is clearly for money. People do that for money. But if, in the case of the trial that I was involved in there was an altruistic element, and I suppose that if they’re sold on the basis that you’re doing some good to the human race, then that’s an incentive, because I think we’re all a bit altruistic, somewhere.

If people were tempted to do it just for the money, I’d say, “Do you really need the money? Or is there another source for the money?” Because I don’t have a good feeling about those kind of trials. And, as Northwick Park* has proved, they can be dangerous. But if you have an interest in a particular condition that you have, and I mean if it’s new treatments for life-threatening diseases, for example, and especially if you have been diagnosed with one of those diseases, I think yeah, it’s worth a go, you know. There’s a long way to go in terms of finding cures for a lot of diseases so if we can contribute, then that’s a good contribution.

Are you glad you took part, thinking back?

Yes, I am, yeah.

*FOOTNOTE'David is referring to a Phase 1 trial at a commercial research unit based at Northwick Park Hospital in 2006 when 6 healthy volunteers became extremely ill. ‘First-time-in-humans’ studies are carried out precisely because we need to find out about possible risks and side effects before giving the treatment more widely. Most of the people we talked to took part in trials of treatments which had already been tested in humans before. A copy of the Inquiry Report of this incident can be downloaded from the Department of Health website.